RECRUITING

Rifaximin SSD in Dementia Trial

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Conditions

Dementia Alzheimer TypeDementia Associated With Cerebrovascular Diseasedementiarifaximingut-brainAlzheimer'svascular dementia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Using a new formulation of rifaximin, a non-absorbable antibiotic, to test if it can affect microbes in the gut of patients with dementia favorably.

Official Title

Rifaximin in Dementia Trial (RIDE): Gut-Brain Modulation With Rifaximin SSD in Dementia

Quick Facts

Study Start:2024-12-30
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06718686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Probable Alzheimer's Disease (AD) or Vascular Dementia (VaD) mild or moderate based on Clinical Dementia Rating Scale.
  2. * Males and Females Age ≥ 65 years
  3. * Community living with availability of caregiver to accompany participant to study visits and to participate in the study.
  4. * Able to consent or legal guardian who can consent (with participant assent).
  5. * Legally authorized representative (LAR) and caregiver for the study is the same individual.
  6. * Fluency (both participant and caregiver) in written and spoken English to participate in study visits.
  1. * Dementia not due to AD or VaD
  2. * Clinically significant agitation or aggression (requiring treatment with antipsychotic medication)
  3. * Delusions and/or hallucinations
  4. * Severe psychopathology including major depression
  5. * Unstable, severe, or poorly controlled medical conditions evident from physical examination or clinical history
  6. * Visual and/or hearing disorder that prevents completion of neuropsychologic evaluations.
  7. * Diarrhea
  8. * Hypersensitivity to rifaximin, components of rifaximin,
  9. * and any rifamycin antimicrobial agent
  10. * Antibiotic use in the prior 6 months
  11. * Taking medications that interact with Rifaximin. P-glycoprotein (P-gp) inhibitor treatment is permitted as long as the use of P-gp inhibitors is discussed with the investigator.
  12. * History of alcohol and/or drug abuse
  13. * Participation in another investigational drug trial in the last 30 days

Contacts and Locations

Study Contact

Jasmohan S Bajaj, MD
CONTACT
804-675-5802
jasmohan.bajaj@vcuhealth.org
Haley Obolewicz, RN
CONTACT
804-675-5705
haley.obolewicz@va.gov

Principal Investigator

Jasmohan Bajaj
PRINCIPAL_INVESTIGATOR
Richmond VA Medical Center

Study Locations (Sites)

Richmond VA Medical Center
Richmond, Virginia, 23249
United States

Collaborators and Investigators

Sponsor: Jasmohan Bajaj

  • Jasmohan Bajaj, PRINCIPAL_INVESTIGATOR, Richmond VA Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-30
Study Completion Date2026-05

Study Record Updates

Study Start Date2024-12-30
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • dementia
  • rifaximin
  • gut-brain
  • Alzheimer's
  • vascular dementia

Additional Relevant MeSH Terms

  • Dementia Alzheimer Type
  • Dementia Associated With Cerebrovascular Disease